US Supreme Court Sets New Limits on Owning the "Laws of Nature"

Wed, 03/28/2012 - 22:37pm

In patent law, they have a saying: the name of the game is the claim. And when it comes to patenting the naturally occurring elements of plants, the human body and other living things, patent lawyers have shown themselves to be highly ingenious in making their claims. Their goal, of course, is to own any knowledge about nature that is needed by lots of people and can be sold. Patent law lets companies establish artificial chokepoints over knowledge that should belong to all of us, giving the “owner” the right to charge a toll and stifle potential competition.

This trend got its start in 1980 when the U.S. Supreme Court first allowed the patenting of lifeforms in the Chakrabarty case, which allowed the patenting of microorganisms. That in turn opened the floodgates to the patenting of genes, plants, bioengineered crops, and much else. Harvard University famously owns the patent of a specially bred mouse for cancer experiments, the “onco-mouse.” There is much to be said for the fruits of biotech research, but there is also much to be lamented and condemned as far as the needless privatization of knowledge and stifling of competition and innovation.

Now it seems as if the tide could be turning against the patenting of nature The U.S. Supreme Court just ruled unanimously that a diagnostic medical test that determines levels of metabolites in a person’s blood (in order to administer the proper dosage of a class of drugs known as thiopurines) cannot be patented. The case, Mayo Collaborative Services v. Prometheus Laboratories, arose when the Mayo Clinic in Minnesota decided to develop its own metabolite diagnostic test and stop buying the Prometheus product. Prometheus sued, saying that the Mayo Clinic’s self-devised diagnostic test violated its patent. The Mayo Clinic responded that no one can own basic knowledge about human physiology and nature.

Perhaps it was inevitable that the U.S. Supreme Court would have to step up to stop the nonsense. The patenting of nature was bound to get out of hand and cause serious ethical, social and economic problems. In this case, Justice Steven Breyer, writing for the Court, stated, "Laws of nature, natural phenomena and abstract ideas are not patentable," adding that “an application of a law of nature... must do more than simply state the law of nature while adding the words 'apply it'.” The Mayo ruling overturned a lower court ruling in favor of Prometheus Laboratories.

This is very good news for keeping knowledge about living systems open and free for all to use. What makes this ruling especially satisfying is that the Supreme Court also vacated the decision of an appeals court in an explosive case involving patents on human genes related to breast cancer and ovarian cancer.

Several years ago, the ACLU, the Public Patent Foundation and others filed a lawsuit against Myriad Genetics and the University of Utah Research Foundation claiming that the patents on two human genes known as BRCA1 and BRCA2 are invalid and unconstitutional. The ACLU et al. argued that the patents were preventing others from researching breast cancer treatments and denying women medical choices. The proprietary claims over the genes were essentially blockading research into an important disease.

Myriad claimed that it had not patented the genes themselves but rather “isolated” versions of them. It said that its tests focused on distinctive chemical forms of the genes as isolated from the body, and not on the genes as they exist in the human body. A hair-splitting distinction? That’s what patent attorneys are all about. The name of the game is to state the claim!

But here’s what so rich: After making its ruling in Mayo v. Prometheus, the Supreme Court also directed the federal appeals court to reconsider its ruling in the Myriad patent case in light of the Mayo ruling. These two decisions should be sending shivers down the spins of the biotech industry and venture capitalists. Imagine – serious boundaries on what aspects of nature and life can be patented!

The Court’s rulings will now encourage new research and investment in in areas where it can truly add value rather than simply giving one player monopoly rights over a core field of basic knowledge. The new standard, plainly stated by the Court, may help channel investment to where it can really make a difference in developing medical treatments. The glimmer of a recognition that ownership is not the supreme value and that other ethical and social values have standing! It will be fascinating to see how the appeals court will deal with the Myriad patent case – and how this body of jurisprudence evolves in the mid-term.

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